Egypt

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  • Organisation Info.
  • Resources
  • Supplementary Info.

National Organization for Drug Control & Research

Country
Egypt

Institution website address
http://www.nodcar.eg.net/contactus.htm

Organisation Info.

Type of Organisation
National

What is the institutional affilliation of your Organisation
Government

What is the operational language(s) of your MRA/DRA?
Arabic, English

 

Medicines Regulatory Authority

Administrator's name or contact person E-mail
pharinfo@pharmaco.sti.sci.eg

Telephone number: +2 02 3749 6077

Fax Number: +2 02 3379445

Physical address
51 Wezaret El-Zeraa st. Dokki, Cairo, Egypt

 

Who We Are...?
 
The national organization for drug control and research “NODCAR” is a component of the Ministry of Health, established on
1976 under a presidential decree.
 
It encompassed two establishments formerly known as the “Drug Research and Control center and the analytical drug
administration”
 
According to the decree, NODCAR has been delegated different responsibilities with identified goals aiming at the
implementation of a competent national quality control authority.
 
Goals & Objectives
 
1. Quality control of pharmaceutical products, biologics, cosmetics, medical devices, raw
    materials, veterinary products,household insecticides and medicinal plants and natural
    products.
 
2. Analysis of samples of new products, products under registration and products that need
    re-evaluation to assess their compliance with the specifications and standards required for
    ensuring their safety and effectiveness.
 
3. Development of new analytical methods and product standards.
 
4. Active contribution in the scientific activities, committees, conferences and seminars relevant to Nod Car's specialization.
 
5. Conduct scientific research and development aiming at constant refining of the testing methodology and researching ways
    to improve them. Collaboration with the universities and specialized institutions is an integral part of this activity.
 
6. Continuous upgrading of scientific capabilities of NODCAR's personnel through training programs and guidance provided by
    scientific advisors and consultants.
 
7. Bioavailability and bioequivalence studies and bioresearch on animals to supply NODCAR with crucial information about the
    safety and effectiveness of the marketed products. Clinical testing is to be authorized by NODCAR and should follow the
    international standards and end ethics.
 
8. Issuance of scientific publications concerning information on new products, regulations adopted concerning the use of some
    products, side effects and adverse reactions of drugs.
 
9. Review, evaluate and give advice on the scientific contents included in the information sheets of the products and general
    advertising on drugs and cosmetics especially informational 
 
10. Within, existing rules and regulations and in collaboration with other regulatory authorities, NODCAR inspects
      manufacturing processes and takes samples for in –process control as applicable.
 
11. Extend its services within the context of its specialization to other Arab and regional countries subject to approval of the
     Minister of Health and concerned authorities

 

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